Ultra Low Frequency Neuromodulation for Nociceptive Chronic Low Back Pain
Recruiting now · Not applicable
Conditions studied: Nociceptive Pain, Axial Back Pain
In brief
The goal of this clinical trial is to learn if Ultra Low Frequency (ULF) neuromodulation works to treat nociceptive chronic low back pain in adults. It will also evaluate the safety of ULF therapy. The main questions it aims to answer are: * Does ULF neuromodulation reduce chronic low back pain? * What, if any, unexpected medical problems do participants experience when treated with ULF neuromodulation? Researchers will compare ULF therapy to conventional treatments for chronic low back pain. Participants will: * Be randomly assigned to either the study device or to conventional medical treatments * Undergo standard surgical procedures to place the study device if assigned to the device arm * Attend regular clinic visits over 24 months for checkups and data collection
Key facts
- Study ID
- NCT06763653
- Run by
- Presidio Medical, Inc
- People needed
- 303
- Starts
- 2025-01-17
- Expected to finish
- 2029-04-01
- Last updated by the study team
- 2025-01-24
Who can join
Age: 22 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Chronic, intractable nociceptive axial low back pain with or without leg pain (VAS ≥6 cm for back pain over 7 days) for a minimum of 3 months.
- Symptoms have failed to respond adequately to conservative therapies, including: physical therapy/exercise, medications, and interventional therapies.
- Back pain greater than leg pain.
- ODI score ≥30 and ≤80.
- On stable pain medications or on no pain medications.
- Considered medically stable and a suitable surgical candidate.
- Able to operate the device.
- Willing to sign the Human Research Ethics Committee (HREC)/Institutional Review Board (IRB) approved informed consent form.
- Willing and deemed capable of complying with the requirements of the study protocol, including attending all scheduled visits.
- Twenty-two (22) years of age or older.
- Able to complete questionnaires independently.
You may not qualify if…
- Have a systemic condition or disease not stabilized or judged by the investigator to be incompatible with participation in the study.
- Suffer from severe cognitive impairment that would impair ability to complete subject questionnaires or operation of the device.
- Diagnosed with an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance, intervention and/or ability to evaluate treatment outcome as assessed by a clinical psychologist or psychiatrist.
- Presence of spinal stenosis, structural spinal abnormality, or spinal instrumentation observed on MRI or CT that would make lead placement unsafe or untowardly difficult.
- Previous experience with neuromodulation devices for pain.
- Opioid usage with average total daily morphine equivalent dose (MED) of >100 mg.
- Have an untreated addiction to alcohol or other drugs within 6 months of screening visit.
- Have a cardiac demand pacemaker, implanted defibrillator, or another implanted electronic device.
- Have a known hypersensitivity to any of the procedural agents or materials in the study device that is inserted into the subject.
- Have a known need for an MRI or surgery through the end of the study.
- Candidates of child-bearing potential cannot be pregnant nor plan to become pregnant during the study.
- Diagnosed with untreated malicious or malignant neoplasms or have a life expectancy of less than 1 year.
- Be participating in another interventional clinical trial.
Where it is running
- The International Spine Centre — Norwood, South Australia, Australia (enrolling)
- CerCare Pty Ltd — Wayville, South Australia, Australia (enrolling)
- Monash House Research Centre — Clayton, Victoria, Australia (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.